Optimal Relaxation Technique for Laparotomies With Rocuronium Infusion Followed by Sugammadex Reversal (ProjectO5Rs)
Muscle relaxation using rocuronium infusion with sugammadex reversal hypothetically provide better quality of muscle relaxation and rapid recovery from anaesthesia compared with intermittent bolus of rocuronium muscle relaxant which is reversed with neostigmine.
50 patients undergoing major laparotomy surgery with predicted surgical time of more than 90 minutes will be randomised into 2 treatment arms: CI-sugammadex & IB-Neostigmine.
After a bolus of rocuronium given during induction, patients in CI-Sugammadex arm will be started on rocuronium infusion immediately and rate adjusted according to the targeted PTC of 1-2. Patients randomised to IB-Neostigmine will be given boluses of rocuronium at reappearance of TOFC of 2.
At the end of the surgery, the subject will be reversed with either sugammadex or neostigmine at different depth of block, ie PTC 1-2 and TOFC 2 respectively.
Quality of intraoperative relaxation and effectiveness of reversal of the 2 technique, CI-Sugammadex and IB-Neostigmine will be compared with respect to:
Time to full reversal (T4/T1 [TOF] ratios ≥ 0.9) of neuromuscular blockade from:
- PTC 1-2 in CI-Sugammadex group
- TOFC ≥2 in IB-Neostigmine group
- Incidence of residual neuromuscular blockade (T4/T1 ratios < 0.9)
- Improved quality of intraoperative neuromuscular relaxation by maintaining profound neuromuscular blockade, as reflected by reduced incidence of intraoperative events and high VAS grading of relaxation quality by surgeon
Underdosing of Skeletal Muscle Relaxants for Laparotomy
Reversal of Skeletal Muscle Relaxant
Drug: Neostigmine, atropine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Optimal Relaxation With Rocuronium Infusion Followed by Rapid Reliable Reversal With Sugammadex: A Comparison With Conventional Practice|
- speed of reversal [ Time Frame: patient monitored till return of full muscle power usually within 30 mins ] [ Designated as safety issue: No ]Time from start of administration of reversal agent to recovery of the T4/T1 ratio to 0.9.
- Vital signs, i.e. heart rate and blood pressure [ Time Frame: first 24 hours of post op period ] [ Designated as safety issue: Yes ]pre-reversal, post-reversal, recovery and post-anesthetic visit
- intraoperative events [ Time Frame: throughout the operation averagely 3 hours ] [ Designated as safety issue: No ]events suggestive of inadequate paralysis during surgery, a composite incidents of movement, coughing, bucking, breathing against ventilator or surgeon complaining of tight abdomen
- incidence of residual neuromuscular blockade [ Time Frame: 1 hour ] [ Designated as safety issue: No ]composite occurrence of clinical signs of residual muscle weakness like diplopia, ptosis, non sustained head lift, T4/T1 ratio less than 90%
|Study Start Date:||February 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: IB-neostigmine
subject will be given intermittent bolus of rocuronium during the surgery and reversal of neostigmine at the end of surgery at TOF 2
Drug: Neostigmine, atropine
0.05 mg/KG NEOSTIGMINE AND 0.02 MG/ KG ATROPINE at TOF 2
subject will be given continuous infusion of rocuronium and reversal of sugammadex at the end of surgery at PTC 1-2
4 mg/kg sugammadex will be given stat at the end of surgery at PTC 1-2
Other Name: Bridion
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01539044
|Hospital Sulatanah Aminah|
|Johor Bahru, Johor, Malaysia, 80100|
|Principal Investigator:||Dr Maria HS lee, MMed(Anaes)||Clinical research Centre Johor, Malaysia|